Genentech Halts Avastin Approval Filing for Mesothelioma

Chemotherapy

In 2015, data was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting from a Phase III French study that demonstrated improved survival rates for patients who received bevacizumab (Avastin® Genentech, Inc.) in addition to the standard chemotherapy regimen of pemetrexed/cisplatin.

The outcome of the study prompted the independent French cooperative group and Genentech to file for a new indication from the Food and Drug Administration (FDA) for Avastin to be approved for use in malignant pleural mesothelioma. Unfortunately, the filing process has now been halted.

Roche, of which Genentech is a subsidiary, released the following statement:

The Phase III MAPS study of Avastin in first-line malignant pleural mesothelioma was sponsored and conducted by an independent French cooperative group (the French Collaborative Thoracic Intergroup, IFCT). The results of the trial were presented at ASCO in 2015 and published in The Lancet . This trial was conducted for publication purposes and was not intended to support a regulatory approval. Based on the outcome of the study and from initial liaison with the cooperative group, it was considered the study may be suitable for filing a new indication license for Avastin in malignant pleural mesothelioma.

IFCT and Roche have been working closely together for more than a year and a half on the preparation of the MAPS database for filing, and were executing the necessary steps required in order to enable this filing with FDA, EMA and other health authorities.

After careful and comprehensive review of the data, Roche has determined that the MAPS study was not fully conducted according to registrational standards. We have therefore decided to not submit an application dossier to global health authorities for a new indication for Avastin in malignant pleural mesothelioma. Global regulatory authorities, including the EMA and FDA, are being informed about this decision. 

Roche is very disappointed to announce this decision not to file Avastin in malignant pleural mesothelioma.

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